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Life Sciences
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Pharma manufacturer minimizes compliance risk in batch delivery

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Pharma Manufacturer Minimizes Compliance Risk in Batch Delivery

Background

With a significant focus on pharmaceutical manufacturing, this $15B organization operates multiple manufacturing locations in the USA, Central and South Americas, Europe and Japan, and specializes in developing and delivering a wide range of health and wellness products. Their operations involve meticulous batch delivery workflows, quality assurance processes, and strict adherence to global regulatory standards, as expected in the consumer health industry.

Challenges

The manufacturer struggled with managing the many different types of files required in their batch delivery workflows. They needed to convert all these files into PDFs for uniform storage, but the diverse range of materials—like product specifications, ingredients, formulas, raw materials, and packaging details—added complexity. This made it hard to keep a consistent and efficient document management system, leading to several issues:

  1. Process Inefficiencies: The manual effort required to handle various file types and ensure their proper rendering into PDFs was time-consuming and resource-intensive.
  2. Documentation Inconsistencies: Variability in file formats and the manual conversion process led to inconsistencies in documentation, affecting the accessibility and reliability of critical information.
  3. Compliance Risks: Inconsistent documentation and inefficient workflows posed significant compliance risks, threatening the company’s adherence to stringent industry regulations.

Solution

The organization implemented Adlib into their batch delivery, quality assurance, and manufacturing workflows, capturing batch records from a variety of sources, such as eQMS, MES, email inbox and DMS. Adlib's robust rendering capabilities allows for the automatic conversion of all file types into standardized PDFs, smart assembly, OCR and technical validation, regardless of their origin.

This implementation brought several key benefits:

  1. Streamlined Document Management: Adlib ensures that all materials, from product specifications to packaging specifics, are consistently and efficiently stored as PDFs. This eliminates the need for manual conversions and reduces 90% of errors.
  2. Increased Efficiency: By automating the rendering process, the company achieved greater efficiency in their workflows. The reduction in manual effort allowes employees to focus on more critical tasks, improving productivity by 20%.
  3. Enhanced Consistency and Accessibility: The standardization of document formats improved the consistency and accessibility of information, saving up to 80% of time and resources for teams to locate and retrieve necessary documents.
  4. Improved Compliance and Operational Efficiency: The automation and standardization provided by Adlib enhanced the company's compliance with regulatory standards, eliminating 100% of negative audit outcomes and FDA citations associated with 21 CFR Part 211.
“Every file type is rendered through Adlib as all materials are required to be stored as PDFs. The files we are processing can be a mixture of different things such as product specifications, ingredients, formulas, raw materials used in products, or specifics of packaging. Adlib is integrated with Enovia, our active quality management tool. We rely heavily on that tool,”– Sr. Manager Platform
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Our engineering teams are constantly creating new schematics and blueprints within AutoCAD or MicroStation which need to be managed and archived. These CAD files would have far too many layers if they were not rendered so they need to be processed through Adlib first. Adlib delivers excellently converted AutoCAD renditions, which is highly important to us. These can be complex images so accurately transferring the detail is critical.

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I do view Adlib as being a stronger solution than others.

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Adlib is likely the best option on the market today. Adlib does a great job processing huge volumes with strong quality. Adlib is constantly online and processing files nightly 24/7. Our organization can’t really function without Adlib being operational, it is heavily embedded in the work we do.

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Many people drop documents in a folder which is monitored by Adlib. Anything that is placed in our vault must first go through Adlib, so they eventually get their hands on basically any document we receive or create.

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All the documents we are rendering are signed certificates ensuring that ships have been appropriately inspected. Our documents are relatively large and contain charts, graphs, and drawings. We want these rendered correctly and concisely so each certificate is accurate and professional looking. Adlib helps to add our logos, a watermark, and make the entire certificate look that much more professional. The fact that the renderings are really clean and well-formatted is a key benefit of Adlib.

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When we made the decision to change rendering solutions back in 2016, we looked towards 3 separate vendors. Overall, Adlib seemed more mature as a software option.

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We process all digital insurance claims through Adlib. The documents for claims can be quite robust, and commonly need to be files from many parties like police reports, fire and safety documents, and images.

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I like that Adlib has designed a fairly niche product within the PDF rendering space. It is very good at what it does while remaining accurate and fast.

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We initially looked at OpenText, but it didn’t meet our upfront requirements. I would happily give Adlib a positive referral. They deserve a 10 out of 10, as I view them as the strongest option available.

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Adlib is integrated with Enovia, our active quality management tool. Every file type is rendered through Adlib as all materials are required to be stored as PDFs. The files we are processing can be a mixture of different things such as product specifications, ingredients, formulas, raw materials used in products, or specifics of packaging.

Sr. Manager Platform
A large pharmaceutical manufacturer
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The majority of the documents we are rendering through Adlib are preclinical study reports, new drug developments, and general clinical documents. Due to how heavily regulated life sciences is, 100% of our documents are required to be transferred to and stored as a PDF. Working with the likes of Adlib keeps us complaint.

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Adlib is fully embedded within M-Files. They have paired very well with each other which has kept us happy. When we were selecting Adlib, a key reason we did so was due to Adlib telling us how easily their software partners with other systems.

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A leading contract research organization
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